OR WAIT null SECS
The historic FDA approval of pegcetacoplan marks the first and only approved treatment for geographic atrophy. In a new interview, Dr. Wykoff expresses what approval means for patients with the debilitating disease.
Last week, the US Food and Drug Administration (FDA) approved pegcetacoplan injection (SYFOVRE™) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The approval for the therapy from Apellis Pharmaceuticals was significant, as it marked the first and only-FDA approved treatment for GA. Positive results from the phase 3 OAKS and DERBY trials at 24 months suggested the therapy reduced the rate of GA lesion growth compared with sham, with increased treatment effects over time.
In an interview with HCPLive, Charles Wykoff, MD, PhD, Director of Clinical Research, Retina Consultants of Texas, expressed his excitement about a success that has taken years and the meaningful impact the pegcetacoplan approval will have on both patients and the field in general.
“I think that the first thing I would say is, to me, this is the most important advance in retina care in over a decade,” Wykoff said. “We as retina specialists, to anyone that’s in eye care, deal extensively with patients with macular degeneration. The biggest unmet need in that category has been a treatment for geographic atrophy.”
Retina care over the last 20 years has seen the introduction of various treatments for retina diseases, with Wykoff comparing this approval to the introduction of anti-vascular endothelial growth factor (anti-VEGF) injections. The approval now validates complement as a clinically relevant target and may accelerate research on further therapeutics, according to Wykoff.
He additionally notes that pegcetacoplan will not improve visual function in patients with GA and he doesn’t want patients to have “false hope” about visual improvement with the medication. However, the relevant information that Wykoff wants to communicate to patients is that the therapy may preserve retinal tissue and there will be a long-term increase in visual function for a patient.
“I feel confident communicating to patients that these medications are effective at slowing the progression, the efficacy appears to increase over time,” he said. “It is really important that that gets communicated that the longer we treat these patients, we think that it will have a greater benefit on tissue preservation. And over time, that will translate into improved visual function compared to where they would have been with natural history.”
Safety signals, including an observed increased rate of development of wet age-related macular degeneration, may require consistent retinal imaging and efficient diagnoses, according to Wykoff. Intraocular inflammation (IOI) was additionally identified in patients in the phase 3 program using pegcetacoplan.
“The package insert is very clear that patients can continue dosing with this medication after that inflammation has resolved, which from my perspective, distinguishes this type of inflammation from inflammation that we’ve seen from other therapeutics in the past where once there was IOI with a medication, you really want to discontinue that medication permanently,” he said.
Wykoff described two patient populations in which he has centered a conversation around pegcetacoplan. This first group included wet AMD patients receiving anti-VEGF injections, who are looking forward to a treatment that will slow the progression of the advanced dry component of their disease.
“I’ve had that conversation with dozens of patients over the last week to even a few months, talking about how exciting it is to have this medication,” he said. “Those are really the first ones I think are lining up to get access to this medication as soon as we have it commercially.”
The second indicated group is patients with GA without wet AMD concurrently, with Wykoff marking it clear that the potential treatment decision may be up to the patients. In an ideal situation, patients will be foveal preserved, and clinicians could slow down progression before it involves the fovea. But, as Wykoff notes, the challenge is that many patients are high functioning and may not want to receive regular injections inside the eye.
“Some of these patients absolutely do want to receive injections and I plan to treat them,” he said. “Some of them may be more inclined to wait until they experience more substantial visual decline and then initiate therapy. The challenge with waiting is we know these drugs are effective, but they don’t stop progression.”
As a take-home point, Wykoff reiterated the excitement of the pegcetacoplan approval, noting treatment for GA has been a huge unmet need for a generation of patients.
“There's a lot of detail here to communicate to patients, it's important they understand all the nuances of the efficacy and the safety data,” he said. “But in that context, to me, this was the most important advance in retina care in over a decade.”